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510(k) K040811

VARELISA SSDNA ANTIBODIES, MODEL 14896 by Pharmacia Deutschland GmbH — Product Code LRM

K040811 is an FDA 510(k) premarket notification submitted by Pharmacia Deutschland GmbH for the device "VARELISA SSDNA ANTIBODIES, MODEL 14896". The FDA issued a decision of Substantially Equivalent on May 13, 2004. The device falls under product code LRM (Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Pharmacia Deutschland GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2004
Date Received
March 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Pharmacia Deutschland GmbH

  • K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796 (July 2, 2004)
  • K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496 (May 14, 2004)
  • K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796 (May 11, 2004)
  • K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896 (May 11, 2004)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (May 11, 2004)
  • K040452 — VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096 (May 11, 2004)
  • K020758 — VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 (May 2, 2002)
  • K020757 — VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 (May 2, 2002)
  • K020752 — VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 (May 2, 2002)

Other clearances for product code LRM

  • K101319 — IMMULISA DSDNA ANTIBODY ELISA (December 9, 2010)
  • K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) (April 15, 2009)
  • K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT (November 21, 2006)
  • K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST (September 11, 2000)
  • K000477 — MDI DS-DNA TEST (March 1, 2000)
  • K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM (February 18, 2000)
  • K993727 — BINDAZYME ANTI-DSDNA EIA KIT (December 21, 1999)
  • K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 (December 18, 1998)
  • K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUN (November 18, 1998)
  • K980391 — SERAQUEST ANTI-DSDNA (April 24, 1998)

FDA data resources